04
Aug

Webinar: Drug Supply Chain Security Act: Legal Overview and Cross-Enterprise Compliance Strategies (August 11, 2020 @1:00-2:00 PM ET)

In 2019, FDA issued the first Warning Letter for violations of the Drug Supply Chain Security Act, signaling its heightened attention to supply chain and distribution issues. Since DSCSA was enacted in 2013, various provision have come into effect. It is important for companies not just to understand the law’s requirements, but also how to […]

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22
May

WHY YOUR QUALITY CULTURE MATTERS NOW MORE THAN EVER

Nothing is normal these days.   We’ve learned to be creative in everything we do during this crisis, from where and how we work, to finding scarce resources in both our work and personal lives.  Rules have changed to accommodate circumstances, and expectations have been colored by those changes.  Take for example FDA’s Emergency Use Authorization […]

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08
May
Document Issued for Manufacturing Facility Information Image

Even In the Face of COVID 19, the Beat Still Goes On

Although though we are in the grips of a pandemic and our attention is focused on the development of treatments and vaccines for COVID-19, manufacturing of drug products to treat other conditions is continuing, and GMPs must still be maintained. Sponsor companies continue to manufacture products and are still dependent upon products and services from […]

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01
May
Hope word made by female hands, family creation, expectancy of baby, happiness

FDA Grants EUA for Remdesivir

No, this is not an approval, but it is an emergency use authorization to use the antiviral Remdesivir for COVID 19 patients.  The FDA issued this EUA on Friday, in record time, after positive results of the study involving Gilead’s drug.  The EUA will remain in effect until the COVID 19 public health emergency is […]

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